(100 days)
This Blood Pressure Monitor is intended for use in measuring blood pressure and pulse rate in patients with arm circumferences from 16 to 36 cm (6.3 to 14.1 inch), 22 to 42cm (8.6 to 16.5 inch), 22 to 45cm (8.6 to 17.7 inch) or 40 to 52cm (15.7 to 20.5 inch).
Cuff model AC1636-01, arm circumference range is 16-36cm (6.3 to 14.1 inch), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or preeclampsia.
Cuff model AC2245-021, arm circumference range is 2245cm (8.6 to 17.7 inch), which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia. Cuff model AC2242-41 and cuff model AC4052-04, arm circumference range are 22-42cm (8.6 to 16.5 inch) and 4052cm (15.7 to 20.5 inch) respectively, which are intended for adults without conditions of diabetes, pregnancy, or pre-eclampsia.
It is intended indoor use only.
The Blood Pressure Monitor is designed to measure the systolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor is the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 160mm and 520 mm, includes the inflatable bladder and polyester shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the electromagnetic deflation control valve and the LCD.
The devices embed a Cellular Wireless network connections module that allows it to connect to receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse rate, date and time by Wireless method and protocol.
Here is a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ANSI/AAMI/ISO 81060-2:2019 and ISO 81060-2:2018/Amd.1:2020) | Reported Device Performance (TMB-2092-G with new cuffs) |
|---|---|
| Criterion 1: Mean difference between reference BP and device readings for SBP | -0.02 ± 2.12 mmHg (AC2242-41 study) |
| -0.56 ± 1.58 mmHg (AC4052-04 study) | |
| Criterion 1: Mean difference between reference BP and device readings for DBP | 0.17 ± 1.97 mmHg (AC2242-41 study) |
| -0.24 ± 1.63 mmHg (AC4052-04 study) | |
| Criterion 2: Mean difference between reference BP and device readings for SBP | -0.02 ± 1.49 mmHg (AC2242-41 study) |
| -0.56 ± 0.98 mmHg (AC4052-04 study) | |
| Criterion 2: Mean difference between reference BP and device readings for DBP | 0.17 ± 1.51 mmHg (AC2242-41 study) |
| -0.24 ± 1.12 mmHg (AC4052-04 study) | |
| Overall conclusion for both new cuffs (AC2242-41 and AC4052-04) | Fulfilled both validation criteria 1 and 2 of ANSI/AAMI/ISO 81060-2:2019 and ISO 81060-2:2018/Amd.1:2020. |
Note: The exact numerical acceptance criteria for ANSI/AAMI/ISO 81060-2:2019 are not explicitly stated in the provided text, but the text confirms that the device fulfilled these criteria. Typically, Criterion 1 relates to the mean difference and standard deviation of differences, and Criterion 2 relates to the standard deviation of differences for individual subjects.
2. Sample size used for the test set and the data provenance
- Sample Size: 172 general adult subjects in total across two clinical studies.
- First clinical study (AC2242-41): 86 subjects, with 258 datasets collected.
- Second clinical study (AC4052-04): 86 subjects, with 258 datasets collected.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective clinical validation studies for the accuracy of the blood pressure monitor with the new cuff sizes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, blood pressure monitor clinical validation (like ISO 81060-2) typically involves multiple trained observers (e.g., two or three) to take reference blood pressure measurements using a validated sphygmomanometer (often mercury or validated auscultatory method) to establish the ground truth. These observers are usually trained clinical professionals.
4. Adjudication method for the test set
The document does not explicitly state the adjudication method. In ISO 81060-2 studies, ground truth is typically established by multiple observers (as mentioned above) taking simultaneous or nearly simultaneous measurements, and a consensus or average of these readings serves as the reference and deviations between observers are often within predefined limits.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the clinical studies described evaluate the performance of the device itself in measuring blood pressure and pulse rate, without direct human intervention in the measurement process (beyond applying the cuff and initiating the measurement). The results (-0.02 ± 2.12 mmHg, etc.) represent the standalone performance of the algorithm.
7. The type of ground truth used
The ground truth was established by reference blood pressure measurements. In the context of ANSI/AAMI/ISO 81060-2, this typically refers to auscultatory measurements performed by human observers using a standardized reference sphygmomanometer.
8. The sample size for the training set
The document does not provide information regarding a separate training set. The clinical studies mentioned are validation studies (test sets) to prove the accuracy of the device against established standards. For an oscillometric blood pressure monitor, the algorithm itself is developed based on physiological models and extensive internal testing, not typically a separate "training set" in the machine learning sense that would be reported in this manner for a 510(k) submission.
9. How the ground truth for the training set was established
As no training set is explicitly mentioned in the context of this 510(k) submission for an oscillometric BPM, how its ground truth was established is not provided. The "ground truth" discussed for these types of devices relates to the clinical accuracy validation against reference measurements, as detailed in point 7.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).